Ignite Creation Date:
2024-05-06 @ 3:36 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02323880
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2014-12-16
Brief Title:
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase 1 Study of Selinexor KPT-330 A Selective XPO1 Inhibitor in Recurrent and Refractory Pediatric Solid Tumors Including CNS Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system CNS tumors that have come back recurrent or do not respond to treatment refractory Drugs used in chemotherapy such as selinexor work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading
Detailed Description:
PRIMARY OBJECTIVES
I To determine the recommended phase 2 dose RP2D or the maximum tolerated dose MTD of the tablet formulation of selinexor in children with recurrentrefractory solid and CNS tumors
II To describe the toxicities of selinexor in children with recurrentrefractory solid and CNS tumors
III To characterize the pharmacokinetics of the tablet formulation of selinexor in children with recurrentrefractory solid and CNS tumors
SECONDARY OBJECTIVES
I To determine the antitumor effect of selinexor in a preliminary manner in children with recurrentrefractory solid and CNS tumors
II To determine the pharmacodynamic properties of selinexor in children and adolescents with refractory solid tumors in plasma proteins and whole blood ribonucleic acid RNA
III To explore the penetration pharmacodynamic effects and biologic effects of selinexor in tumor tissue of patients with recurrentrefractory high-grade gliomas HGG requiring resection
IV To further assess the toxicity and antitumor effects of selinexor in children with recurrentrefractory HGG in expanded cohorts following dose-escalation by measuring rate of objective radiographic response medical patients and rate of progression-free survival PFS six months from the start of treatment surgical patients
OUTLINE This is a dose escalation study
Patients receive selinexor PO on either a twice weekly days 1 3 8 10 15 17 or once weekly days 1 8 15 and 22 schedule Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
I To determine the recommended phase 2 dose RP2D or the maximum tolerated dose MTD of the tablet formulation of selinexor in children with recurrentrefractory solid and CNS tumors
II To describe the toxicities of selinexor in children with recurrentrefractory solid and CNS tumors
III To characterize the pharmacokinetics of the tablet formulation of selinexor in children with recurrentrefractory solid and CNS tumors
SECONDARY OBJECTIVES
I To determine the antitumor effect of selinexor in a preliminary manner in children with recurrentrefractory solid and CNS tumors
II To determine the pharmacodynamic properties of selinexor in children and adolescents with refractory solid tumors in plasma proteins and whole blood ribonucleic acid RNA
III To explore the penetration pharmacodynamic effects and biologic effects of selinexor in tumor tissue of patients with recurrentrefractory high-grade gliomas HGG requiring resection
IV To further assess the toxicity and antitumor effects of selinexor in children with recurrentrefractory HGG in expanded cohorts following dose-escalation by measuring rate of objective radiographic response medical patients and rate of progression-free survival PFS six months from the start of treatment surgical patients
OUTLINE This is a dose escalation study
Patients receive selinexor PO on either a twice weekly days 1 3 8 10 15 17 or once weekly days 1 8 15 and 22 schedule Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA097452 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA097452 |
| NCI-2014-02410 | REGISTRY | None | None |
| ADVL1414 | None | None | None |
| ADVL1414 | OTHER | None | None |
| ADVL1414 | OTHER | None | None |